Nab-paclitaxel Combined With Gemcitabine as Adjuvant Therapy for Pancreatic Cancer After Curative Resection
Information source: Fudan University
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stage IA Pancreatic Adenocarcinoma; Stage IB Pancreatic Adenocarcinoma; Stage IIA Pancreatic Adenocarcinoma; Stage IIB Pancreatic Adenocarcinoma
Intervention: nab-paclitaxel (Drug); gemcitabine (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Xian-Jun Yu Official(s) and/or principal investigator(s): Xian-Jun Yu, M.D., Ph.D., Principal Investigator, Affiliation: Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University
Overall contact: Xian-Jun Yu, M.D., Ph.D., Phone: +86-21-64175590, Email: yuxianjun88@hotmail.com
Summary
Pancreatic cancer has an extremely poor prognosis with a 5-year survival rate of less than
5%. About 25% of patients have the opportunity for radically surgical resection when
diagnosis. However, the recurrence rate is up to 85% within 2 years. Data from clinical
trials indicated that gemcitabine-based adjuvant chemotherapy reduced recurrence and
enhanced overall survival for patients who have undergone surgery to remove their tumor.
Nab-paclitaxel could enhance the intratumoral concentration of gemcitabine; recent studies
showed that nab-paclitaxel plus gemcitabine significantly improved progression-free survival
and overall survival of metastatic pancreatic cancer patients. The present study is intended
to investigate the activity and safety of the combination of gemcitabine and nab-paclitaxel
as adjuvant chemotherapy in treating patients with pancreatic cancer after curative
resection.
Clinical Details
Official title: A Phase II, Single-arm Study to Evaluate the Efficacy and Safety of the Combination of Nab-paclitaxel and Gemcitabine in Treating Patients With Pancreatic Cancer After Curative Resection
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Recurrence-free survival at one year after curative resection
Secondary outcome: Overall survival after curative resectionQuality of life score after curative resection Number of grade 3 and 4 toxicities according to NCI CTCAE version 4.0 CA199 level after curative resection
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Signed informed content obtained prior to treatment
- Age ≥ 18 years and ≤ 75 years
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Patients must have histologically confirmed pancreatic adenocarcinoma (or any mixed
pathology if adenocarcinoma is predominant) after curative resection (R0). The
pathological staging does not exceed the stage IIB.
- No tumor lesions are seen by abdominal and thoracic CT scan 4~8 weeks after surgery,
and no serious adverse events are occurred during this period
- The expected survival after surgery ≥ 6 months
- White blood cell (WBC) ≥ 3 × 109/L; Absolute neutrophil count (ANC) ≥ 1. 5 × 109/L;
Platelets (PLT) ≥ 100 × 109/L; Hemoglobin (Hgb) ≥ 9 g/dL
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]/
alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase [SGPT]) ≤ 2. 5 ×
institutional upper limit of normal (ULN); Total bilirubin (TBIL) ≤ ULN; Creatinine
(CRE) ≤ 1. 5 × ULN
- Prothrombin time (PT) and international normalized ratio (INR) ≤ 1. 5 × ULN
Exclusion Criteria:
- Active second primary malignancy or history of second primary malignancy within the
last 3 years
- Patients who have received any form of anti-tumor therapy before surgery, including
chemotherapy, radiotherapy, interventional chemoembolization, radiofrequency
ablation, and molecular targeted therapy
- Use of any other investigational agents
- Patients with uncontrolled intercurrent illness including, but not limited to ongoing
or active infection, internal hemorrhage, pancreatic leakage, bile leakage,
symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,
or psychiatric illness/social situations that would limit compliance with study
requirements
- History of allergic reactions attributed to compounds of similar chemical or
biological composition to nab-paclitaxel or gemcitabine
- Metabolic acidosis, acute or chronic, including ketoacidosis
- Pregnant or nursing women
- Human immunodeficiency virus (HIV)-positive patients
- Patients who are unwilling or unable to comply with study procedures
Locations and Contacts
Xian-Jun Yu, M.D., Ph.D., Phone: +86-21-64175590, Email: yuxianjun88@hotmail.com
Department of Pancreatic and Hepatobiliary Surgery, Fudan University Shanghai Cancer Center; Pancreatic Cancer Institute, Fudan University; 270 Dong An Road, Shanghai 200032, China, Shanghai 200032, China; Recruiting Xian-Jun Yu, M.D., Ph.D., Phone: +86-21-64175590, Email: yuxianjun88@hotmail.com Liang Liu, M.D., Ph.D., Phone: +86-21-64175590, Email: liuliang.zlhospital@gmail.com Xian-Jun Yu, M.D., Ph.D., Principal Investigator
Additional Information
Starting date: January 2014
Last updated: March 5, 2015
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